Administrative reasons

The purpose of this study is to evaluate the effect of TRC101 on the progression of chronic kidney disease (CKD) and to evaluate the safety profile of TRC101 in CKD patients with metabolic acidosis.

This is a randomized, double-blind, placebo-controlled trial. Eligible subjects will be randomized in a 1:1 ratio to TRC101 or placebo. The primary endpoint of the study will be progression of renal disease, defined by time to first occurrence of any event in the composite endpoint consisting of a confirmed ≥ 40% reduction in eGFR, end-stage renal disease (ESRD), and renal death. The study will terminate when the independent blinded Clinical Endpoint Adjudication Committee has positively adjudicated the targeted number of primary efficacy endpoint events. The maximum duration of follow-up for a randomized subject is anticipated to be approximately 6 years.

Inclusion Criteria:

• Estimated glomerular filtration rate (eGFR) 20 - 40 mL/min/1.73m^2.
• Serum bicarbonate 12 - 20 mEq/L.
• On maximum tolerated dose of ACE inhibitor and/or ARB.

Exclusion Criteria:

• Acute metabolic acidosis.
• Anticipated dialysis or kidney transplant within 6 months.
• Recent acute kidney injury.